Class 2 Device Recall BHM Kwiktrak Gate System

• Date Initiated by Firm: August 01, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on January 05, 2010
• Recall Number: Z-2434-2008
• Recall Event ID: 49102
• Product Classification: Non-Ac-Powered Patient Lift - Product Code FSA
• Product: Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; ; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560); ; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. ; ; The equipment is intended for transferring lifts from one system track to another.
• Code Information: part 700.11560, serial numbers GA-1304-0001 to GA-2608-1374, and part 700.11550, all units
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave Ste A; Roselle IL 60172-1684
• For Additional Information Contact: Ms. Traci Giovenco; 800-323-1245 Ext. 6125
• Manufacturer Reason for Recall: There is a possibility that the Kwiktrak Gate System could malfunction, resulting in the gate locks opening even though the corresponding tracks are not properly aligned.
• FDA Determined Cause: Device Design
• Action: Arjo Inc. USA sent Urgent Field Safety Notice letters dated 8/1/08 to the direct accounts on 8/1/08, informing them that there is a remote possibility that the gate system could malfunction. The result of this malfunction is that the gate locks could open even though the corresponding tracks are not properly aligned. This could result in the lift/cassette falling off the track system, possibly resulting in serious personal injuries and or property damage. The letters requested the customer to immediately implement special operating instructions in their facility to ensure great care is used when the gate system is operated. All personnel must be made aware that the tracks need to be properly aligned before using the gate. Illustrations of an unaligned gate system with an open lock and properly aligned tracks and gate system with open locks were included. Any questions the customers may have were directed to the Arjo Quality Department at 1-800-323-1245, ext. 6125. The accounts were informed that Arjo personnel will contact them in September 2008 to install a permanent add-on improvement to prevent the occurrence of a malfunction. The accounts were requested complete the enclosed response form indicating that they have read and understood the 8/1/08 letter, and fax it back to Arjo at 888-594-2756.
• Quantity in Commerce: 230 units
• Distribution: Nationwide Distribution --- including states of Arizona, Colorado, Illinois, Indiana, Michigan, Minnesota, Missouri, Montana, New York, North Carolina, Ohio, Oklahoma, Texas, and Wisconsin.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.